| 产品号 | 商品名 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 参比药物(RLD) | 生物等效参考标准(RS) | 治疗等效代码 | 该申请号批准日期 | 该产品号批准日期 | 市场状态 |
|---|---|---|---|---|---|---|---|---|---|---|
| 001 | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | No | No | AP | 2009/09/14 | 2009/09/14 | Prescription |
| 002 | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | No | No | AP | 2009/09/14 | Prescription |
| 提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级；罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
|---|---|---|---|---|---|---|
| 2015/09/01 | SUPPL-3（补充） | Approval | Labeling | STANDARD | ||
| 2014/09/18 | SUPPL-2（补充） | Approval | Labeling | STANDARD | ||
| 2011/03/31 | SUPPL-1（补充） | Approval | Labeling | |||
| 2009/09/14 | ORIG-1（原始申请） | Approval |
| 关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
|---|---|---|---|---|---|---|---|---|---|
| 无 | |||||||||
| 关联产品号 | 独占权代码 | 失效日期 | 备注 |
|---|---|---|---|
| 无 | |||
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 077187 | 001 | ANDA | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | Prescription | No | No | AP | 2008/06/30 | HIKMA |
| 078096 | 001 | ANDA | GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | Prescription | No | Yes | AP | 2008/06/30 | FRESENIUS KABI USA |
| 078258 | 001 | ANDA | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | Prescription | No | No | AP | 2008/06/30 | AMNEAL |
| 078835 | 001 | ANDA | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | Prescription | No | No | AP | 2008/06/30 | SANDOZ INC |
| 078863 | 002 | ANDA | GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | Prescription | No | No | AP | 2008/06/30 | BIONPHARMA |
| 078531 | 001 | ANDA | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | Prescription | No | No | AP | 2009/04/30 | SANDOZ |
| 079078 | 001 | ANDA | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | Prescription | No | No | AP | 2009/09/14 | RISING |
| 078629 | 001 | ANDA | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | Prescription | No | No | AP | 2009/12/23 | HIKMA FARMACEUTICA |
| 091136 | 002 | ANDA | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | Prescription | No | No | AP | 2010/04/09 | MYLAN ASI |
| 204238 | 001 | ANDA | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | Discontinued | No | No | AP | 2016/07/06 | EUGIA PHARMA |
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 077177 | 001 | ANDA | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | Prescription | No | No | AP | 2007/12/31 | HIKMA |
| 077186 | 001 | ANDA | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | Prescription | No | No | AP | 2008/06/30 | HIKMA |
| 077297 | 001 | ANDA | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | Prescription | No | Yes | AP | 2008/06/30 | DR REDDYS |
| 078090 | 001 | ANDA | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | Prescription | No | No | AP | 2008/06/30 | FRESENIUS KABI USA |
| 078258 | 002 | ANDA | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | Prescription | No | No | AP | 2008/06/30 | AMNEAL |
| 078835 | 002 | ANDA | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | Prescription | No | No | AP | 2008/06/30 | SANDOZ INC |
| 078880 | 001 | ANDA | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | Prescription | No | No | AP | 2008/06/30 | BIONPHARMA |
| 078531 | 002 | ANDA | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | Prescription | No | No | AP | 2009/04/30 | SANDOZ |
| 079078 | 002 | ANDA | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | Prescription | No | No | AP | 2009/09/14 | RISING |
| 078629 | 002 | ANDA | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | Prescription | No | No | AP | 2009/12/23 | HIKMA FARMACEUTICA |
| 091137 | 002 | ANDA | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | Prescription | No | No | AP | 2010/04/09 | MYLAN ASI |
| 204238 | 002 | ANDA | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | Discontinued | No | No | AP | 2016/07/06 | EUGIA PHARMA |